System for delivering an anvil assembly to a surgical site

ABSTRACT

An anvil assembly delivery system includes an anvil assembly having a center rod and an anvil head assembly pivotally secured to the center rod a flexible tube having a first end configured for oral insertion into a patient and a second end engaged with the anvil assembly, and a retrieval suture connected to the head assembly positioned to extend from the anvil assembly in a direction opposite to the flexible tube. The anvil assembly delivery system also includes a spacer suture tube positioned adjacent the anvil head assembly and defining a suture channel, which is supported on the retrieval suture and is dimensioned to prevent the retrieval suture from becoming trapped in the staple line of a stapling device. In an embodiment, the spacer is a suture tube defining a suture channel which receives the retrieval suture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/194,475, filed Nov. 19, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/831,905, filed Dec. 5, 2017, now U.S. Pat. No.10,154,845, which is a continuation of U.S. patent application Ser. No.14/313,283 filed Jun. 24, 2014, now U.S. Pat. No. 9,867,619, the entirecontents of each of which are incorporated by reference herein.

TECHNICAL FIELD

The present disclosure relates generally to a system for delivering ananvil assembly to a surgical site. More specifically, the presentdisclosure relates to a system for delivering an anvil assembly to asurgical site including a retrieval suture and guide tube.

BACKGROUND

Surgical anastomosis procedures using a circular stapler often requiretrans-oral delivery of an anvil assembly to a surgical site. In knownprocedures, a suture can be attached to the anvil assembly to facilitateretrieval of the anvil assembly from the surgical site after completionof a stapling operation. During such procedures, complications canresult if the retrieval suture becomes trapped in the staple line.

SUMMARY

An anvil assembly delivery system is provided which includes an anvilassembly including a center rod and an anvil head assembly secured tothe center rod, and a flexible tube having a first end configured fororal insertion into a patient and a second end. The anvil assembly isconnected to the second end of the flexible tube. A retrieval suture isconnected to the head assembly and is positioned to extend from theanvil assembly in a direction opposite to the flexible tube. A spacer issupported on the retrieval suture adjacent the anvil head assembly. Thespacer is dimensioned to prevent the suture from being clamped betweenthe anvil head assembly and a stapling instrument and becoming trappedin a staple line.

In embodiments, the spacer includes a suture tube defining a suturechannel and the retrieval suture extends through the suture channel.

In certain embodiments, the anvil head assembly is movable from a firsttilted position to a non-tilted operative position.

In certain embodiments, the suture tube has an outer diameter orthickness of between 0.0625 inches and 0.50 inches. In otherembodiments, the suture tube has an outer diameter or thickness ofbetween 0.0625 inches and 0.25 inches. In some embodiments, the suturetube has an outer diameter or thickness of about 0.25 inches.

In embodiments, a tensioning member is connected to the anvil headassembly to maintain the anvil head assembly in the first tiltedposition.

In certain embodiments, the anvil head assembly defines first openingsand the tensioning member includes a first suture. The first sutureextends through the first openings and into an opening in the flexibletube.

In embodiments, the anvil head assembly is pivotal from the operativenon-tilted position to a second tilted position which is different thanthe first tilted position.

In certain embodiments, the anvil assembly further comprises a rotatablecam member and a plunger. The plunger is spring biased into contact withthe cam member and movable distally to rotate the cam member to effectmovement of the anvil head assembly from the first tilted position tothe operative non-tilted position.

In embodiments, the cam member is rotatable and the plunger is movabledistally to move the anvil head assembly from the operative tiltedposition to a second tilted position different than the first tiltedposition.

In certain embodiments, an adapter is provided to connect the anvilassembly to the second end of the flexible tube.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed tilt anvil assembly aredisclosed herein with reference to the drawings wherein:

FIG. 1 is a perspective view of a surgical stapling device including anembodiment of an anvil assembly according to the present disclosure;

FIG. 2 is a first perspective side view of the anvil assembly of FIG. 1in the non-tilted position;

FIG. 3 is a second perspective side view of the anvil assembly shown inFIGS. 1 and 2;

FIG. 4 is an exploded side view of the anvil assembly of FIGS. 1-3;

FIG. 5 is an end view of the anvil assembly of FIGS. 1-3;

FIG. 6 is a cross-sectional side view of a distal end of the tilt anvilassembly of FIGS. 1-4 taken along line 6-6 of FIG. 5 and showing thehead assembly in the non-tilted operative position;

FIG. 7 is a cross-sectional side view of a distal end of the anvilassembly of FIGS. 1-6 taken along line 7-7 of FIG. 5 and showing thehead assembly in the non-tilted operative position;

FIG. 8 is an enlarged side view of the cam latch member of the anvilassembly of FIGS. 1-4;

FIG. 9 is a top view of the anvil assembly of FIGS. 1-4 supported on ananvil delivery system;

FIG. 10 is an enlarged exploded view of the anvil delivery system ofFIG. 9;

FIG. 11 an enlarged top view of the anvil delivery system of FIGS. 9 and10, including the anvil assembly of FIGS. 1-4 shown in the first tiltedposition tensioned by the suture;

FIG. 12 is a cross-sectional side view of the anvil assembly and anvildelivery system of FIG. 11 taken along lines 12-12 of FIG. 11;

FIG. 13 is a cross sectional side view (showing the area of detail ofFIG. 12) of the anvil assembly of FIGS. 1-4, in a pre-fired tiltedposition supported on the anvil delivery system of FIG. 9;

FIG. 14 is an enlarged view of portion 14 of FIG. 13;

FIG. 15 is an illustration of the surgical stapling instrument of FIG. 1and the anvil delivery system of FIG. 9 with the anvil delivery systeminserted trans-orally into a patient and the stapling instrumentinserted through an incision in the stomach;

FIG. 16 is an enlarged side view of the distal head portion of thesurgical stapling device of FIGS. 1 and 15;

FIG. 17 is an enlarged side view of the distal head portion of thesurgical stapling device of FIGS. 1 and 15, showing the anvil assemblyof FIGS. 1-4 received thereon.

FIG. 18 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. 1, including theconnected anvil assembly of FIGS. 1-4 shown in an approximated pre-firednon-tilted operative position;

FIG. 19 is an enlarged cross-sectional side view of the distal headportion of the surgical stapling device of FIG. 1, including theconnected anvil assembly of FIGS. 1-4 shown in a post-fired non-tiltedoperative position;

FIG. 20 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-4 in the post-fired non-tilted operativeposition corresponding to the position of FIG. 19;

FIG. 21 is an enlarged cross-sectional side view of the distal end ofthe anvil assembly of FIGS. 1-4 in a post-fired second tilted position;

FIG. 22 is a cross-sectional side view of the anvil assembly of FIGS.1-4 in a post-fired second tilted position (corresponding to theposition of FIG. 21) shown supported on an anvil retainer of thesurgical stapling device of FIG. 1;

FIG. 22A is another cross-sectional side view of the anvil assembly ofFIGS. 1-4 corresponding to the anvil assembly position of FIG. 22;

FIG. 23 is an enlarged view showing the designated area of detail ofFIG. 22A;

FIG. 24 is a side view of the anvil assembly of FIG. 22 supported on theanvil retainer of the surgical stapling device of FIG. 1;

FIG. 25 is a side, perspective view of the anvil assembly including aproximal suture tube;

FIG. 26 is an illustration of the surgical stapling instrument of FIG. 1and the anvil delivery system of FIG. 9 with the anvil delivery system,including the proximal suture tube of FIG. 25, inserted trans-orallyinto a patient and the stapling instrument inserted through an incisionin the stomach; and

FIG. 27 is an enlarged view of the indicated area of detail shown inFIG. 26.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed anvil assembly will now bedescribed in detail with reference to the drawings in which likereference numerals designate identical or corresponding elements in eachof the several views. Throughout this description, the term “proximal”will refer to the portion of the instrument closer to the operator andthe term “distal” will refer to the portion of the instrument furtherfrom the operator.

FIG. 1 illustrates an embodiment of a surgical stapling deviceconfigured for use with a tilt anvil assembly according to the presentdisclosure. Briefly, surgical stapling device 10 includes a proximalhandle assembly 12, an elongated central body portion 14 including acurved elongated outer tube 14 a, and a distal head portion 16. Thelength, shape and/or the diameter of body portion 14 and distal headportion 16 may also be varied to suit a particular surgical procedure.

With reference still to FIG. 1, handle assembly 12 includes a stationaryhandle 18, a firing trigger 20, a rotatable approximation knob 22 and anindicator 24. A pivotally mounted trigger lock 26 is fastened to handleassembly 12 and is manually positioned to prevent inadvertent firing ofstapling device 10. Indicator 24 is positioned on the stationary handle18 and includes indicia, e.g., color coding, alpha-numeric labeling,etc., to identify to a surgeon whether the device is approximated and isready to be fired. Head portion 16 includes an anvil assembly 110 and ashell assembly 31. A more detailed discussion of surgical stapler 10 isdisclosed in U.S. Pat. Nos. 7,364,060 and 7,303,106, the contents ofwhich are incorporated herein by reference in its entirety.

Referring now to FIGS. 2-7, an embodiment of the anvil assembly of thepresent disclosure is shown generally as reference numeral 110. Anvilassembly 110 is shown in a non-tilted or operative position wherein thestaple deforming pockets 130 face the staple slots of the instrument.Anvil assembly 110 includes a head assembly 112 and a center rodassembly 114. Head assembly 112 includes a post 116, a housing 118, abackup member or plate 120, a cutting ring 122, a cutting ring cover123, an anvil plate 124, a spacer or washer 125, a cam latch member 126,and a retainer member 127. Post 116 is monolithically formed with andcentrally positioned within housing 118. Alternately, housing 118 andpost 116 may be formed separately and fastened together using a knownfastening technique, e.g., welding.

As will be discussed in further detail below, housing 118 includesopenings 119 a, 119 b sized and dimensioned to receive one or moresutures or tensioning members “S”. During use, a first suture “S₁” (FIG.11) is inserted through openings 119 a and is used to retain headassembly 112 in a retracted or first tilted position (FIGS. 11 and 12)during insertion of anvil assembly 110 within a patient. That is, suture“S₁” operates as a tensioning member to maintain the head assembly inthe first tilted position. A second suture “S₂” is inserted throughopenings 119 b and is configured to permit retrieval of tilt anvilassembly 110 from within a patient if desired. During trans-oralinsertion of anvil assembly 110, suture “S₂” extends from the mouth ofpatient, permitting the anvil assembly 110 to be retrieved trans-orally.As shown, second suture “S₂” extends in a direction opposite thedirection of suture “S₁”.

With reference still to FIGS. 2-7, anvil plate 124 is supported in anouter annular recess 128 of housing 118 and includes a plurality ofstaple deforming pockets 130 for receiving and deforming staples. Atleast one tab 124 a extends radially outwardly from anvil plate 124 andis received within a cutout 132 formed in an outer rim of housing 118.Tab 124 a and cutout 132 function to align or properly position anvilplate 124 within annular recess 128 of housing 118.

With particular reference to FIGS. 4, 6 and 7, head assembly 112 will bedescribed in detail. Backup plate 120 includes a central opening 134which is positioned about post 116 within an inner annular recess 136 ofhousing 118 between post 116 and outer annular recess 128. Backup plate120 includes a raised platform 120 a. Cutting ring 122 includes anopening 122 a having a configuration substantially the same as platform120 a. Although platform 120 a is illustrated as having a circularshape, other configurations are envisioned, e.g., square, rectangular,triangular, etc. In one embodiment, cutting ring 122 is formed frompolyethylene and is fixedly secured to backup plate 120 using, forexample, an adhesive, to form a backup plate/cutting ring assembly.Backup plate 120 is formed from a hard material, e.g., a metal.Alternately other materials of construction may be used to constructbackup plate 120 and cutting ring 122. Further, backup plate 120 andcutting ring 122, in the alternative, can be formed as a single orunitary structure.

Still referring to FIGS. 6 and 7, a cutting ring cover 123 is secured toan outwardly facing or proximal surface of cutting ring 122 using, forexample, an adhesive. In one embodiment, cutting ring cover 123 isformed from a material or materials, which have a hardness greater thanthat of the cutting ring, e.g., mylar. In one embodiment, cutting ringcover 123 includes two layers of mylar (not shown) which are joinedtogether using an adhesive and a polypropylene coating. Alternately,cutting ring 122 need not have a cover. Cutting ring 122 and backupplate 120 are slidably mounted about post 116. Backup plate 120 includesa pair of inwardly extending fingers 138 which will be described infurther detail below.

With reference still to FIGS. 4, 6 and 7, retainer member 127 ispositioned in inner annular recess 136 between backup plate 120 and aback wall 118 a of housing 118. In one embodiment, retainer member 127is annular and includes a plurality of deformable tabs 127 a whichengage a rear surface of backup plate 120. Retainer member 127 preventsbackup plate 120 and cutting ring 122 from moving or being pushed intoinner annular recess 136 of housing 118 until a predetermined forcesufficient to deform tabs 127 a has been applied to the backupplate/cutting ring assembly. The predetermined force can be close to butis less than the force applied by an annular cutting blade of a surgicalstapling device when it engages, for example, the cutting ring of anvilassembly 110. In one embodiment by way of example, the predeterminedforce is between about ten pounds and about ninety pounds and can beabout thirty (30) pounds. When the predetermined force is reached, e.g.,during cutting of tissue, backup plate 120 is urged into inner annularrecess 136 and compresses retainer member 127. It is envisioned thatother crushable, deformable, collapsible or movement restricting membersmay be used to retain the backup plate/cutting ring assembly in a fixedposition until a predetermined force has been applied to the backupplate/cutting ring assembly.

As illustrated in FIG. 4, anvil center rod assembly 114 includes acenter rod 152, a plunger 154 and plunger spring 156. A first end ofcenter rod 152 includes a pair of arms 159 which define a cavity 159 a.Each arm 159 has a transverse through bore 158 which is aligned with acentral longitudinal axis of center rod 152. Alternately, through bores158 can be offset from the longitudinal axis of center rod 152. Post 116of anvil head assembly 112 is dimensioned to be positioned within cavity159 a and also includes a transverse through bore (not shown). A pivotmember 162 pivotally secures post 116 to center rod 152 via the throughbores such that anvil head assembly 112 may be pivotally mounted toanvil center rod assembly 114.

Turning briefly to FIG. 8, cam latch member 126 includes a body 126 ahaving a through bore 126 b. Through bore 126 b is dimensioned toreceive pivot member 162 such that cam latch member 126 is pivotallymounted within transverse slot 172 (FIG. 3) of post 116 about pivotmember 162. Referring now to FIGS. 3, 6 and 7, cam latch member 126includes a first body portion 126 c which extends partially from slot172 of post 116 and is positioned to be engaged by a finger 166 ofplunger 154. First body portion 126 c is configured such that thedistance between the surface of first body portion 126 c and throughbore 126 b increase in a clockwise direction about cam latch member 126.In this manner, plunger 154 is able to move forward as cam latch member126 rotates in a clockwise direction. Additionally, this configurationof first body portion 126 c permits plunger 154 to be retracted as camlatch member rotates in a counter-clockwise direction. Cam latch member126 also includes an edge 126 f, including a tab 126 g. A leadingportion of edge 126 f is configured to be urged into engagement with aninner periphery 120 b of backup plate 120 by an engagement finger 166 ofplunger 154 when anvil head 112 is in its non-tilted or operativeposition. Tab 126 g is configured to engage backwall 118 a of housing118 to prevent cam latch member 126 from rotating counter-clockwiserelative to housing 118.

With reference to FIG. 6, plunger 154 is slidably positioned in a bore164 formed in the first end of center rod 152. Plunger 154 includes anengagement finger 166 which is offset from the pivot axis of anvil headassembly 112 and biased into engagement with edge 126 c of cam latch126. Engagement of finger 166 with edge 126 c of cam latch 126 presses aleading portion of edge 126 f against an inner periphery of back plate120 to urge anvil head assembly 112 to an operative or non-tiltedposition on center rod 152. In this non-tilted position, finger 166remains spaced proximally from post 116 of anvil assembly 110.

Turning to FIG. 7, in the pre-fired operative position of head assembly112, i.e. when head assembly 112 has been pivoted to its non-tiltedposition, fingers 138 formed on backup plate 120 engage protrusions 152b adjacent top surface 152 a of center rod 152 to prevent head assembly112 from pivoting about pivot member 162.

Anvil head assembly 112 may be tilted a degrees (FIG. 13) relative toanvil center rod assembly 114 to the pre-fired first tilted position bythe suture “S₁” as described below for insertion. In one embodiment,anvil head assembly 112 is tilted less than ninety degrees andpreferably about seventy degrees (70°) in its pre-fired tilted position;however it should be understood that tilting head assembly 112 to otherdegrees is also contemplated. Tilting of anvil head assembly 112relative to anvil center rod assembly 114 by the suture S1 causes camlatch member 126 positioned within the inner periphery of the backupplate 120 to rotate, causing body portion 126 c of cam latch member 126to engage finger 166 of plunger 154. As cam latch assembly 126 rotatescounterclockwise (as viewed in FIG. 14) with the tilting of anvil headassembly 112, plunger 154 is retracted within bore 164 of anvil centerrod assembly 114, thereby compressing spring 156. In this manner, finger166 of plunger 154 is distally biased against body portion 126 c of camlatch member 126.

With reference to FIGS. 3 and 4, a second end of center rod 152 includesa bore 180 defined by a plurality of flexible arms 182. Flexible arms182 each include an opening 182 a dimensioned to receive a projectionformed on or connected to a shell assembly 31 (FIG. 18). Alternatively,openings 182 a may be configured to receive a suture for permittingretrieval of anvil assembly 110. The proximal ends of each of theflexible arms 182 include an internal shoulder 184 dimensioned toreleasably engage shell assembly 31 of surgical stapling device 10 tosecure anvil assembly 110 to the surgical stapling device. A pluralityof splines 186 are formed about center rod 152. Splines 186 function toalign anvil assembly 110 with the staple holding portion of a surgicalstapling device. Center rod 152 also includes an annular recessedportion 190 to facilitate grasping of anvil assembly 110 by a surgeonwith a grasper. Recessed portion 190 may include a roughened or knurledsurface or an overmold to facilitate grasping of anvil assembly 110.

With reference now to FIGS. 9-12, a system for delivering anvil assembly110 within a patient is shown generally as anvil delivery system 50.Anvil delivery system 50 includes a flexible tube 52 and an adapter 62.Flexible tube 52 includes an open end 52 a. Adapter 62 and anvilassembly 110 are supported on open end 52 a of flexible tube 52. Openend 52 a of flexible tube 52 includes a through bore 53 extendingtherethrough configured to receive a locking pin 54. In embodiments,locking pin 54 can be omitted. Open end 52 a further includes an opening55, used for alignment of the printing on the tube 50 duringmanufacture. Closed end 52 b of flexible tube 52 is configured fortrans-oral insertion in a patient. Flexible tube 52 may include markingsor other gradations 56 along the length thereof to indicate to a surgeonhow much of flexible tube 52 has been received within the patient duringinsertion and/or to indicate the length of flexible tube 52 remaining inthe patient during removal.

With particular reference to FIG. 10, adapter 62 includes a first end 62a configured to be received within open end 52 a of flexible tube 52 anda second end 62 b configured to be received within bore 180 formed incenter rod 152 of anvil assembly 110. First end 62 a includes a seriesof annular rings 64 configured to frictionally retain first end 62 a ofadapter 62 within open end 52 a of flexible tube 52. Second end 62 b ofadapter 62 includes a longitudinal guide member 66 configured to bereceived between flexible arms 182 formed in center rod 152 of anvilassembly 110. In addition, second end 62 b of adapter 62 is sized toallow center rod 152 of anvil assembly 110 to freely slide into and offsecond end 62 b of adapter 62. Adapter 62 further includes a firstthrough bore 70 formed in a central hub portion 62 c as well as secondand third through bores 72, 74 formed in first end 62 a. Through bore 72is configured to align with through bore 53 formed in open end 52 a offlexible tube 52 and is sized to receive locking pin 54. As discussedabove, in embodiments the locking pin 54 can be omitted. As such bore 72can be omitted and adapter 62 can be secured to flexible tube 52 viafrictional engagement between rings 64 and an inner surface of the tube52. Bore 74 is configured to receive both ends of the suture 51. Bore 70can also receive the suture ends to enhance retention.

With particular reference now to FIGS. 10-14, anvil assembly 110 issupported on anvil delivery system 50. Securing anvil assembly 110 toanvil delivery system 50 requires that suture “S₁” is thread throughopenings 119 a (shown also in FIG. 2) formed on anvil head 112 such thatfirst and second ends of suture “S₁” are positioned on different sidesof center rod 152. Second end 62 b of adapter 62 is positioned withinthrough bore 180 of center rod 152 such that longitudinal guide 66 isreceived between two of arm members 182. Each of the first and secondends of suture “S₁” is inserted through bore 74 (FIG. 10) formed inadapter 64 and through open end 52 a of flexible member 52. Anvil head112 is then rotated to a first tilted position as first and second endsof suture “S₁” are pulled through opening 74, applying tension on theanvil head forcing it to pivot counterclockwise as viewed in theorientation of FIG. 13. Such pivoting forces plunger 154 proximally asdescribed above.

First end 62 a of adapter 62 is inserted into open end 52 a of flexiblemember 52. The frictional contact between annular rings 64 of first end62 a of adapter 62 and an inner surface of flexible tube 52 securesadapter 62 to flexible tube 52 and prevents suture “S₁” from looseningas it is clinched between the outer wall of the adapter 62 and innerwall of flexible tube 52. It is envisioned that more than one suture maybe used to secure anvil head assembly 112 in a pre-fired tiltedposition. It is also envisioned that the suture S₁ need not be passedthrough bore 74 but instead is just clamped between the adapter 62 andthe inner wall of the flexible tube 52.

With reference also to FIG. 15, a method for delivering anvil assembly110 to a surgical site within a patient will be described. In onemethod, anvil assembly 110 is provided in the first tilted positionsupported on anvil delivery system 50 and ready for delivery.Alternatively, a clinician secures anvil assembly 110 to anvil deliverysystem 50 as discussed above. With anvil assembly 110 secured toflexible tube 52, the surgeon inserts closed end 52 b of flexible tube52 in the patient's mouth “M” and moves closed end 52 b along withflexible tube 52 down through esophagus “E” to a surgical site, i.e.,the stomach “St”.

After insertion, the surgeon then makes a first incision “I₁” at thesurgical site (stomach “St” as shown) to create an inner access toclosed end 52 b of flexible tube 52 and then pulls closed end 52 b offlexible tube 52 through first incision “I₁”. In some procedures it maybe beneficial to pull flexible tube 52 through incision “I₁” untilcenter rod 152 of anvil assembly 110 advances through first incision“I₁”. When anvil assembly 110 is properly positioned at the surgicalsite, the surgeon releases anvil delivery system 50 from anvil assembly110 by cutting suture “S₁” and separating anvil assembly 110 from secondend 62 b of adapter 62. Flexible tube 52 (with fitting 62) may then bepulled from the body through first incision “I₁”.

Severing of suture “S₁” permits plunger 154 (FIG. 13) to extend fromwithin bore 164 (FIG. 6), thereby causing finger 166 to engage bodyportion 126 c of cam latch member 126. Rotation of cam latch member 126(clockwise as viewed in the orientation of FIG. 14) causes edge 126 f oflatch member 126, engaged with the inner periphery of backup plate 120,to urge anvil head assembly 112 to return to a non-tilted operativeposition (e.g. the position of FIG. 6). Additionally, the distal end ofstapling device 10 may be configured to engage finger 166 of plunger 154as anvil assembly 110 is attached to surgical stapling device 10. Inthis manner, the distal end of surgical stapling device 10 urges plunger154 distally, thereby ensuring the rotation of cam latch 126 and anvilhead assembly 112 to a non-tilted position.

With particular reference to FIG. 15, in one method, a second incision“I₂” is then formed at the surgical site such that distal head portion16 of surgical stapling device 10 may be received therethrough.Alternatively, distal head portion 16 of surgical stapling device 10 maybe received through first incision “I₁” once anvil delivery system 50has been removed therefrom.

Turning briefly to FIGS. 16 and 17, anvil assembly 110 is operablyreceived on an anvil retainer 32 extending from shell assembly 31 formedon a distal end of surgical stapling device 10. Once anvil assembly 110is received on surgical stapling device 10, surgical stapling device 10operates in the manner discussed in U.S. Pat. No. 7,364,060, previouslyincorporated herein in its entirety by reference. Note thatalternatively, suture S1 can be severed after the distal head portion 16of the stapling device 10 receives the anvil assembly 110. Afterattachment, the rotation knob 22 is rotated to approximate the anvilassembly 110 and distal head portion 16 to clamp tissue therebetween,and then the firing trigger is actuated to fires the staples asdisclosed in U.S. Pat. No. 7,364,060.

The operation of anvil assembly 110 will now be described with referenceto FIGS. 18-23. When anvil assembly 110 is in its pre-fired non-tiltedposition (e.g. FIG. 18), backup plate 120 is spaced from backwall 118 aof housing 118 by retainer 127 and protrusions 152 b of center rod 152engage fingers 138 of backup plate 120 (also shown in FIGS. 6 and 7) toprevent tilting of anvil head assembly 112 about pivot member 162.Finger 166 of plunger 154 is urged by spring 156 into engagement withbody portion 126 c of cam latch member 126 to urge cam latch member 126in a clockwise direction (as viewed in FIG. 18), about pivot member 162such that edge 126 f of cam latch member 126 engages inner periphery 120b of backup member 120.

The firing of surgical stapling device 10 causes a knife blade 33thereof to engage cutting ring 122 to move cutting ring 122 and backupplate 120 into annular recess 136 of housing 118 of anvil head assembly112. Arrows “W” in FIG. 19 indicate how cutting ring 122 and backupplate 120 move as a result of the firing of surgical stapling device 10.When such movement occurs, deformable tabs 127 a of retainer 127(labeled in FIGS. 6 and 7) are deformed against backwall 118 a ofhousing 118 and fingers 138 of backup member 120 move away fromprotrusions 152 b of center rod 152. Further, inner periphery 120 b ofbackup plate 120 moves past edge 126 f of cam latch member 126 such thatcam latch member 126 is urged to pivot about pivot member 162 (clockwiseas viewed in the orientation of FIG. 21) in the direction indicated byarrow “X” in FIGS. 21 and 22 by plunger 154 (spring biased distally) toa position in which body portion 126 e of cam latch 126 is positioned infront of and engages backup plate 120. Engagement of plunger 154 withcam latch member 126 urges cam member 126 to further rotate clockwisewhich due to its configuration enables spring biased plunger 154 to movefurther distally so angled surface 167 of plunger 154 contacts thesurface of post 116 of anvil head assembly 112 to move the anvil headassembly 118 to a second tilted position (FIGS. 22A and 23). It is notedthat anvil head assembly 112 will not immediately tilt to its secondtilted position upon firing of surgical stapling device 10 because, uponfiring, anvil head assembly 112 is in an approximated position, i.e.,the anvil head assembly 112 is in close alignment with shell assembly 31of stapling device 10, and, therefore, does not provide room for headassembly 112 to pivot. As such, the anvil head assembly 112 will onlybegin to tilt when anvil assembly 110 and shell assembly 31 of surgicalstapling device 10 are being unapproximated and there is a sufficientgap between the anvil assembly 110 and the distal head portion 16 of thestapling device 10.

As anvil head assembly 112 pivots towards its forward or second tiltedposition, finger 166 of plunger 154 maintains surface 126 e of cam latchmember 126 in contact with backup plate 120 to prevent backup plate 120from sticking to the knife blade as the knife blade is retracted. It isnoted that curved surface 126 e of cam latch member is configured toeliminate any gap and ensure contact between surface 126 e of cam latchmember 126 and backup plate 120 to hold backup plate 120 in place duringand after the knife blade is retracted such that the cutting ring andbackup plate assembly stay in their correct position during continuedtilting of anvil assembly 112. Anvil assembly 110 is configured suchthat anvil head assembly tilts to a forward or second tilted position 13degrees (FIG. 24) relative to center rod assembly 114. As can beappreciated, the anvil head assembly therefore pivots in a firstdirection from an initial (first) tilted position to an untiltedoperative position for application of staples. After firing of theinstrument, the anvil head pivots in the same direction to a secondtilted position. In one embodiment, anvil head assembly 112 is tiltedless than ninety degrees and preferably about seventy degrees (70°) toits second tilted position such that the total pivoting movement of theanvil from the retracted or first tilted position to the forward orsecond tilted position is about one-hundred and forty degrees (140°). Itshould however be noted that the tilting of anvil head assembly 112 toother degrees for the first and/or second tilted position is alsocontemplated.

FIGS. 25-27 illustrate an alternate embodiment of the anvil assemblydelivery system shown generally as 50′ (FIG. 26). Anvil assemblydelivery system 50′ is substantially identical to anvil delivery system50 but further includes a spacer supported on the second or retrievalsuture “S₂”. The spacer is dimensioned to prevent the retrieval suture“S₂” from being clamped between the anvil head assembly 112 and astapling device 10 (FIG. 1) and becoming trapped in a staple line whenthe stapling device 10 is fired. In one embodiment, the spacer includesa suture tube 210 which will be discussed in further detail below. It isalso envisioned that the spacer may comprise any structure which can besupported on the suture “S₂” to prevent approximation of the anvil headassembly 112 and the stapling device 10 to a degree to enable firing aswill be discussed below.

Known stapling devices have lockouts which prevent the surgical staplingdevice from being fired until the anvil assembly and the shell assemblyof the surgical stapling device have been closely approximated into afiring zone. See, e.g., U.S. Pat. No. 7,364,060. Providing a lockout tolock the stapling device to prevent firing of the stapling device untilthe anvil head assembly and stapling device are approximated into thefiring zone ensures that staples ejected from the shell assembly areclose enough to contact the anvil assembly 112 and be properly formed bythe anvil assembly 112 when fired from the stapling device 10.

In the anvil delivery system 50′, the spacer, e.g., suture tube 210, issupported on the suture “S₂” adjacent the anvil head assembly 112. Thesuture tube 210 has a thickness or configuration to preventapproximation of the anvil assembly and shell assembly into the firingzone when the spacer 210 is positioned between the anvil assembly andthe shell assembly. As such, when the suture “S₂” and, thus, the suturetube 210, is inadvertently clamped between the anvil head assembly 112and the stapling device 10, the anvil head assembly 112 is preventedfrom being approximated in relation to the stapling device 10 into thefiring zone to prevent firing of the stapling device 10. This ensuresthat the retrieval suture “S₂” will not become trapped in the stapleline when the stapling device 10 is fired.

As discussed above, the retrieval suture “S₂” is positioned through theopenings 119 b (FIG. 25) formed in the housing 118 of the head assembly112 of the anvil assembly 110. The ends 200 of the suture “S₂” extendfrom the mouth “M” of the patient “P”. In one embodiment, the ends 200extend through a suture tube 210 and are connected to a reel assembly202 which is configured to house and manipulate the retrieval suture“S₂” during delivery of the anvil assembly 110 to the surgical site.Such a reel assembly is disclosed in U.S. application Ser. No.14/078,766 which is incorporated herein by reference in its entirety.

In use, the suture “S₂” is secured to the anvil assembly 110 duringdelivery of the anvil assembly 110 to a surgical site and duringoperation of the stapling device 10. As illustrated, the proximal suturetube 210 defines a suture channel 212 that receives the suture “S₂”. Theproximal suture tube “S₂” is positioned adjacent to the head assembly112 and functions to prevent the suture “S₂” from being clamped betweenthe anvil assembly 110 and the stapling device 10 and getting caught inthe staple line as discussed above. More specifically, when the proximalsuture tube 210 is positioned between the anvil assembly 110 and thestapling device 10, the proximal suture tube 210 has a thickness whichprevents approximation of the anvil assembly 110 and the stapling device10 into the firing zone. As such, when the suture tube 210 is clampedbetween the anvil assembly 110 and the stapling device 10, the staplingdevice 10 will be locked out and cannot be fired. In embodiments, theproximal suture tube 210 has an outer diameter or thickness of between0.0625 inches and 0.50 inches. In other embodiments, the proximal suturetube 210 has an outer diameter or thickness of between 0.0625 inches and0.25 inches. In some embodiments, the suture tube has an outer diameteror thickness of about 0.25 inches. Alternatively, the suture tube 210can have any thickness or configuration which prevents the surgicalstapling device 10 and anvil assembly from being approximated to withinthe firing zone.

It is noted that, in certain embodiments, the suture tube 210 may extendthe full distance, or a substantial portion of the distance, from theanvil assembly to a position externally of a patient's mouth. Inaddition to preventing the retrieval suture from becoming trapped in thesuture line, such an elongated suture tube 210 also functions tomaintain the cleanliness of the suture and prevent contaminants on thesuture from contacting the anastomosis during withdrawal of the suturefrom the surgical site.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the suture tube 210 need notbe tubular but rather can include any structure or configurationattachable to the suture S₂ capable of preventing approximation of thestapling device and the anvil assembly into the firing zone. Therefore,the above description should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the claimsappended hereto.

1. (canceled)
 2. A circular anvil assembly delivery/retrieval systemcomprising: a center rod; an anvil head assembly secured to the centerrod; a retrieval suture connected to the anvil head assembly; and aspacer supported on the retrieval suture adjacent to the anvil headassembly, the spacer dimensioned to prevent the anvil head assembly frombeing approximated in relation to a shell assembly of a surgicalstapling device into a firing zone when the spacer is clamped betweenthe anvil head assembly and the shell assembly.
 3. Thedelivery/retrieval system of claim 2, wherein the center rod supports aplunger having a finger.
 4. The delivery/retrieval system of claim 3,further including a rotatable cam member supported on the center rod,wherein the anvil head assembly is rotatably secured to the center rod,and the plunger is spring biased for movement into contact with the cammember to rotate the cam member and effect movement of the anvil headassembly in relation to the center rod from a first tilted position toan operative non-tilted position.
 5. The delivery/retrieval system ofclaim 4, wherein the plunger is movable distally to move the anvil headassembly from the first tilted position to a second tilted positiondifferent than the first tilted position.
 6. The delivery/retrievalsystem of claim 2, further comprising an adapter connecting the centerrod to a flexible tube.
 7. The delivery/retrieval system of claim 2,wherein the spacer includes a suture tube defining a suture channel, thesuture channel receiving the retrieval suture and being positionedadjacent to the anvil head assembly.
 8. The delivery/retrieval system ofclaim 7, wherein the suture tube is dimensioned to extend from the anvilassembly to a patient's mouth during an anvil delivery procedure.
 9. Thedelivery/retrieval system of claim 4, further including a pivot membercoupling the anvil head assembly to the center rod, the cam memberrotatably mounted about the pivot member and having a body portionincluding an outer surface, wherein a distance between the outer surfaceof the body portion of the cam member and the pivot member increasing ina clockwise direction about the cam member.
 10. The delivery/retrievalsystem of claim 9, wherein the anvil head assembly includes a backupplate having an inner portion, and the cam member has an edge positionedto be urged into engagement with the inner portion of the backup plate.11. The delivery/retrieval system of claim 4, further comprising aflexible tube having a first end configured for oral insertion into apatient and a second end, the anvil assembly being connected to thesecond end of the flexible tube.
 12. The delivery/retrieval system ofclaim 7, wherein the suture tube has an outer diameter of between 0.0625inches and 0.50 inches.
 13. The delivery/retrieval system of claim 11,further including a first suture, wherein the anvil head assemblydefines first openings and the flexible tube defines an opening, thefirst suture extending through the first openings and into the openingin the flexible tube.
 14. An anvil assembly delivery/retrieval systemcomprising: an anvil assembly including a center rod and an anvil headassembly, the center rod extending from one side of the anvil headassembly; a retrieval suture connected to an opposite side of the anvilhead assembly, the retrieval suture dimensioned to extend from apatient's mouth during delivery of the anvil assembly to a surgicalsite; and a spacer supported on the retrieval suture adjacent the anvilhead assembly, the spacer including a suture tube that defines a suturechannel, the suture tube dimensioned to prevent the anvil head assemblyfrom being approximated in relation to a shell assembly of a surgicalstapling device into a firing zone to prevent firing of the staplingdevice, wherein the suture channel of the suture tube receives theretrieval suture and has an outer diameter of between 0.0625 inches and0.50 inches.
 15. The delivery/retrieval system of claim 14, furtherincluding a flexible tube having a first end configured for oralinsertion into a patient and a second end connected to the anvilassembly.
 16. The delivery/retrieval system of claim 15, wherein theanvil head assembly is movable in relation to the center rod from afirst tilted position to a non-tilted operative position.
 17. Thedelivery/retrieval system of claim 15, wherein the suture tube has anouter diameter of 0.25 inches.
 18. The delivery/retrieval system ofclaim 15, further including a first suture, wherein the anvil headassembly defines first openings and the flexible tube defines anopening, the first suture extending through the first openings and intothe opening in the flexible tube.
 19. The delivery/retrieval system ofclaim 16, wherein the anvil assembly further comprises a rotatable cammember and a plunger, the plunger being spring biased into contact withthe cam member and movable distally to rotate the cam member to effectmovement of the anvil head assembly from the first tilted position tothe non-tilted operative position.
 20. The delivery/retrieval system ofclaim 15, further comprising an adapter connecting the anvil assembly tothe second end of the flexible tube.
 21. The delivery/retrieval systemof claim 19, wherein the anvil head assembly includes a backup platehaving an inner portion, and the cam member has an outer edge positionedto be urged into engagement with the inner portion of the backup plate.